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510(k) Data Aggregation

    K Number
    K112142
    Device Name
    DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2011-11-04

    (101 days)

    Product Code
    NDW, JIX
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    NDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder). The Drug 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.
    Device Description
    The LITH method employs a lithium-specific chromoionophore that forms a complex with the Li+ ion in an alkaline solution. The concentration of lithium in the sample is proportional to the increase in absorbance, which is due to the formation of the dye-lithium complex. The reaction is measured using a Bichromatic (510 and 700 mm) endpoint technique. The Drug 4 Calibrator is a five (5) level, liquid calibrator. It is packaged as a kit of ten vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is liquid human serum and contains digoxin and lithium. This product is sold separately from the Flex® reagent cartridge.
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    K Number
    K063684
    Device Name
    COBAS LITHIUM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2008-03-21

    (465 days)

    Product Code
    NDW, JIX
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    NDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).
    Device Description
    The cassette cobas c501 Lithium contains an in vitro diagnostic reagent system intended for use on Roche/Hitachi cobas c systems for the quantitative determination of lithium in human serum and plasma. The test principle is colorimetric.
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    K Number
    K063705
    Device Name
    LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-10-09

    (300 days)

    Product Code
    NDW, DKB, JIX, KLS
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    NDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy. The ISE Calibrators 1 and 2 & 3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in human serum or plasma and lithium in human serum. For the in vitro diagnostic use on the T60 analyzer. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.
    Device Description
    Not Found
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    K Number
    K070987
    Device Name
    SENTINEL LITHIUM ASSAY
    Manufacturer
    SENTINEL CH SPA
    Date Cleared
    2007-08-02

    (118 days)

    Product Code
    NDW
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    NDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.
    Device Description
    The Multigent Lithium test is a spectrophotometric method, which can be readily adapted to automated clinical chemistry analyzers. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change of absorbance, which is directly proportional to the concentration of lithium in the sample.
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    K Number
    K050374
    Device Name
    ADVIA IMS LITHIUM ASSAY
    Manufacturer
    BAYER HEALTHCARE, LLC
    Date Cleared
    2005-06-15

    (121 days)

    Product Code
    NDW, JIX, JJY
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    NDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder. The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder. The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems. The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
    Device Description
    Not Found
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    K Number
    K003583
    Device Name
    LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
    Manufacturer
    TRACE AMERICA, INC.
    Date Cleared
    2001-01-17

    (58 days)

    Product Code
    NDW
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    NDW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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